GMP – How Bad Can It Get?

Dollar Tree, Inc. and its subsidiary Family Dollar Distribution, Inc. recently received a letter from the FDA about violations in their distribution facility. How bad can GMP get? This example shows it can get pretty amazingly disgusting!

What is GMP?

GMP stands for Good Manufacturing Practices. They are practices and procedures that ensure that a product is safe, standardized, and isn’t adulterated.

We mostly think of GMP as applied to the actual manufacturing part (measuring, mixing, packaging, and labeling). However, GMP is broader and includes such things as ensuring the facility is clean, the personnel are trained, materials are correctly stored, and so forth.

The regulations have specific GMP requirements for the manufacture, packaging, and holding/storage for food, nutritional supplements, and drugs. There are guidelines (not regulations) for cosmetic GMP.

For example:

Good manufacturing practices also serve to make sure that a product doesn’t BECOME contaminated with filth (adulterated) after it is made. Introducing a contaminated or adulterated food (including supplements), drug, cosmetic, or device into interstate commerce is a prohibited act.

A Worst Case Example

According to a recent warning letter sent to Dollar Tree, Inc. and their subsidiary Family Dollar Distribution, Inc., the FDA inspected the Family Dollar Distribution facility in West Memphis, Arkansas in the beginning of 2022. That facility holds and distributes various human and animal foods, dietary supplements, cosmetics, over-the-counter drugs, and medical devices.

The inspection found boatloads of evidence that the goods held in the facility had become contaminated. For example (and this is just a selected portion of the violations noted):

• Four dead rat carcasses on a conveyor belt
• A pallet of mixed nuts that had rat urine and poop on it. Multiple bags of nuts were chewed open.
• A pallet of cases of flour, of which 11 had been chewed on. Two mice ran off when the pallet was unstacked.
• Rat droppings in and around a pallet of cases of Chicken Flavor Rice & Pasta Blend. The pallet had rat nesting and tunnelling in the bottom layers and about 20 of the cases had been chewed.
• Live rats were observed crossing the aisles and climbing on the pallet racks.
• Strong smell of dead and decaying rodents, rat poop and urine, and evidence of rat nests in and around the Inventory Control Center and the breakroom.
• Bird droppings on chocolate protein shakes and Vitamin C supplement drops.
• Records from the pest control company documented capture of up to 100 rodents every month in 2020 and the first half of 2021. The internal maintenance team documented 2300 rat captures from March 2021 to September 2021, and 1100 more dead rats removed after fumigation in January 2022. [That’s 5,200 rats removed in less than 18 months!]
• Several dead birds
• Piled up trash extended about 2 feet from the outer walls of the facility
• Food piled up next to or spilling out of the dumpsters.
• Rat poop around chewed bags of dog and cat food.
• Rodent poop and hairs on pallets and boxes of pregnancy tests.
• Tampons, face masks, contact lens solutions, bandages (all medical devices) stored in rat-infested areas.

And this was not the first warning letter to Dollar Tree regarding adulterated products. In late 2019, they received a warning letter stating that some of their foreign contract manufacturers had serious GMP violations for OTC drug and cosmetic manufacturing.

Yikes!

Products were shipped from this facility to over 400 Family Dollar (and maybe Dollar Tree) retail stores after being stored in the rat infested conditions. According to the letter, Family Dollar Distribution knew about the rat infestation in early 2020, but continued to ship products for nearly 2 years!

Voluntary recalls of some items were initiated; there is no indication of the success of the recalls.

In May, 2022, the company informed the FDA they were permanently closing that distribution facility.